Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes

CellMed

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Drug: CM3.1-AC100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196728

CellMed CM3.1-AC100/03

2010-020895-49 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T2DM.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent prior to any study specific procedures
2. Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
3. Male or female patient aged 18 to 75 years at screening, both inclusive
4. BMI >22 to ≤40 kg/m2 at screening

Exclusion criteria

1. Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
2. Fasting C-peptide < 500 pM at screening
3. Acute gastrointestinal symptoms at the time of screening and/or Day -1
4. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 4 patient groups, including a placebo group

CM3.1-AC100 dose A

Experimental group

Description:

Compound CM3.1-AC100 s.c.

Treatment:

Drug: CM3.1-AC100

CM3.1-AC100 dose B

Experimental group

Description:

Compound CM3.1-AC100 s.c.

Treatment:

Drug: CM3.1-AC100

CM3.1-AC100 dose C

Experimental group

Description:

Compound CM3.1-AC100 s.c.

Treatment:

Drug: CM3.1-AC100

Placebo

Placebo Comparator group

Description:

Placebo for compound CM3.1-AC100 s.c.

Treatment:

Drug: CM3.1-AC100